BACKGROUND: Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China. METHODS: This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion. RESULTS: The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon. CONCLUSIONS: Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings. REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans ; Male ; Female ; Anemia/etiology* ; Middle Aged ; Renal Insufficiency, Chronic/complications* ; Glycine/adverse effects* ; Isoquinolines/adverse effects* ; Aged ; Prospective Studies ; Adult ; Hemoglobins/metabolism* ; Treatment Outcome ; China ; Registries ; East Asian People

Cicatricial contracture is likely to occur at the deep burn wound under the armpits after healing, which results in limitation of shoulder abduction and seriously affects the function of upper limbs of patients. Wearing shoulder abduction orthosis is an effective intervention method for cicatricial contracture under the armpits, but the adjustable shoulder abduction orthosis commonly used clinically at present is limited in the adjustable range, and the customized static orthosis can only maintain the corresponding angle of shoulder abduction. Besides, the above two orthosis can only have the function of unilateral extention, and they are time-consuming for patients with need of bilateral extension. Aiming at the problems mentioned above, a combined shoulder abduction orthosis was designed by the Tongren Hospital of Wuhan University & Wuhan Third Hospital. The low temperature thermoplastic sheet was cut, shaped, and assembled according to the patient′s measurement data of abdomen, upper arm, and lumbar to prepare the combined shoulder abduction orthosis. This abduction orthosis can not only extend the cicatrix contracture under the armpits progressively and extensively, so as to effectively prevent the cicatricial contracture under the armpits, but also can select unilateral or bilateral extension based on the contracture limits for shoulder abduction, thus saving time for both medical workers and patients in relevant treatment.

Scar contracture after burn on the back of hand can easily lead to the limitation of flexion function of fingers, which seriously affects daily life activities. Generally, comprehensive rehabilitation treatment is adopted for scar contracture on the back of hand, among which wearing braces is an effective treatment method. However, some braces will limit the normal finger joints or must wait until all the affected fingers heal before they can be worn, and the wearing operation is quite complicated. In order to solve these problems, the author designed and made a finger flexion band, which was used to stretch the patients with limited flexion of finger caused by scar contracture after burn on the back of hand, and achieved good therapeutic effect. According to the measured hand size, the finger flexion band is cut and spliced from the fabric commonly used in daily life. The finger flexion band is designed with finger sleeve, which will not limit the normal finger joints, can interfere with the healed finger in advance, fix the corresponding fingers better, and improve the treatment comfort, especially for children who do not cooperate with the braces wearing. This finger flexion band is simple to make, cheap, convenient to use, and suitable for clinical promotion.

Objective: To investigate the effect of red light combined with hot compress on diabetic peripheral neuropathy (DPN). Methods: From June 2017 to June 2018, 110 patients with DPN admitted to the Department of Endocrinology, Hangzhou Hospital of Traditional Chinese Medicine were selected in the study.The patients were divided into study group (55 cases) and control group (55 cases) according to the random number table method.All patients were given DPN basic care and treatment, with red light in the control group, and red light combined with hot compress in the study group.The motor nerve conduction velocity (MCV) and the sensory nerve conduction velocity (SCV) of the ulnar nerve, median nerve and common peroneal nerve were compared between the two groups before and after treatment.The total scores of the Toronto clinical scoring system (TCSS) were compared between the two groups before and after treatment.The efficacy of the two groups was compared. Results: Before treatment, there were no statistically significant differences in MCV [(40.45±5.33)m/s vs.(40.14±5.08)m/s, t=0.312, P=0.755; (41.15±5.51)m/s vs.(40.86±5.23)m/s, t=0.283, P=0.778; (42.27±5.84)m/s vs.(41.94±5.75)m/s, t=0.299, P=0.766] and SCV [(39.38±4.82)m/s vs.(39.08±4.60)m/s, t=0.334, P=0.739; (40.13±5.45)m/s vs.(39.86±5.15)m/s, t=0.267, P=0.790; (41.18±5.78)m/s vs.(40.89±5.46)m/s, t=0.278, P=0.782] between the ulnar nerve, median nerve and common peroneal nerve in the two groups.After treatment, the ulnar nerve, median nerve and common peroneal nerve of the two groups were treated.The MCV[(48.77±7.25)m/s vs.(44.62±6.30)m/s, t=3.204, P=0.002; (49.35±7.46)m/s vs.(45.36±6.45)m/s, t=3.001, P=0.003; (49.26±7.13)m/s vs.(46.35±6.22)m/s, t=2.281, P=0.025] and SCV[(47.67±6.52)m/s vs.(43.57±5.61)m/s, t=3.535, P=0.001; (47.77±6.63)m/s vs.(44.31±5.14)m/s, t=3.059, P=0.003; (48.33±7.17)m/s vs.(45.12±6.41)m/s, t=2.475, P=0.015] of the two groups were increased, while which of the study group increased more significantly.Before treatment, there was no statistically significant difference in the total scores of TCSS between the two groups [(10.15±1.23)points vs.(10.45±1.51)points, t=1.142, P=0.256]. After treatment, the total scores of TCSS decreased in the two groups, while which of the study group decreased more significantly[(7.22±0.85)points vs.(8.15±0.96)points, t=5.379, P=0.000]. After treatment, the effective rate of the study group was 87.27%, which of the control group was 63.64%, the difference was statistically significant(χ²=8.295, P=0.004). Conclusion The combination of red light and hot compress on DPN has a more prominent clinical effect, which is worthy of wide application.

The change and fixation of dressing are difficult in patients with burn in special sites nf perineum,buttocks,and bilateral thighs.Therefore,we designed and made stretch pants by ourselves for dressing fixation after dressing change in patients with burns in abdomen,buttocks,and bilateral thighs.The stretch pants are made by cutting and splicing elastic fabric according to perimeters of abdomen and legs.The stretch pants are used after wound dressing change,which can fix the dressing stably,accelerate wound healing,and reduce the medical workers' labor intensity of dressing change and economic burden of patients.And patients can walk out of bed early.It's especially suitable for dressing fixation of infants and other patients who are unwilling to cooperate.Besides,it's easy to make with low cost and suitable for clinical promotion.